ACNE CLEANSER- salycilic acid gel

ACNE CLEANSER by

Drug Labeling and Warnings

ACNE CLEANSER by is a Otc medication manufactured, distributed, or labeled by MONAT GLOBAL CORP, Oxygen Development. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 2.00%

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

Uses

• For the treatment of acne
• Helps prevent new acne blemishes from forming

WARNINGS

For external use only

When using this product

• skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irriatation occurs, only use one topical acne treatment at a time.
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right immediately.

Directions

Directions

• Shake well before use
• Start with damp skin
• Apply small amount onto your fingertips and emulsify
• Gently cleanse the skin using circular motions.
• Rinse with warm water and gently pat the skin dry
• Follow with your MONAT skincare Routine

INACTIVE INGREDIENT

Inactive Ingredients

Water, Sodium Cocoyl Glutamate, Propanediol, Sorbeth-230 Tetraoleate, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Niacinamide, Cocamide MIPA, Glycerin, Coconut Acid, Sodium Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, Sodium Chloride, Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Decyl Glucoside, Sorbitan Laurate, Isopropyl Alcohol.

Questions or Comments

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

OUTER PACKAGE

SECONDARY-OUTER PACKAGE

INGREDIENTS AND APPEARANCE

ACNE CLEANSER 
salycilic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78518-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
LAURETH-4 (UNII: 6HQ855798J)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DECYL GLUCOSIDE, .ALPHA.- (UNII: 47YY6O286H)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
COCONUT ACID (UNII: 40U37V505D)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MACLURA COCHINCHINENSIS WHOLE (UNII: X083FY34PH)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78518-011-01	1 in 1 CARTON	04/04/2023
1		120 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	04/04/2023

Labeler - MONAT GLOBAL CORP (027036949)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development		137098492	manufacture(78518-011)